Biota Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the discovery and development of products to prevent and treat serious and potentially life-threatening infectious diseases. The company develops oral, small molecule compounds to treat various respiratory-related viral infections. Its clinical-stage program is laninamivir octanoate, a long-acting neuraminidase inhibitor (NI) that it is developing for the treatment of influenza A and B. The company is also developing BTA-798, also known as vapendavir, which is in Phase 2 for the treatment of human rhinovirus (HRV) infections in patients with moderate to severe asthma. The company completed two Phase 2 trials of vapendavir and completed additional Phase 1bioavailability and drug-drug interaction studies in healthy volunteers that support its continued development. In addition to these Phase 2 clinical-stage development programs, the company is developing orally bioavailable F and non-F protein compounds for the treatment of respiratory syncytial virus (RSV) infections in children, the elderly and immune-compromised patients. The company is conducting Investigational New Drug application-enabling studies with BTA-C585, the lead compound from its F-protein inhibitor program. Strategy Key elements of the company’s strategy include focusing its resources on the development of its antiviral product candidates; managing its internal research, development and general and administrative expenses at a level that is reasonably similar to its anticipated royalty revenues; evaluating and considering in-licensing, merger, acquisition, co-development or other similar transactions to bolster its clinical-stage development pipeline; and seeking to out-license laninamivir octanoate. Research and Development For the year ended June 30, 2014, the company’s research and development expense included $17.5 million. Intellectual Property Rights and Patents Zanamivir, a NI approved for the treatment and prevention of influenza A and B, is marketed worldwide as Relenza by GlaxoSmithKline (GSK). The Relenza patent portfolio, which is solely owned by the company and exclusively licensed to GSK, is scheduled to expire as follows: December 2014 in the U.S., May 2015 in Australia, 2016 in the major countries of the European Union (EU), and July 2019 in Japan. The company has a commercialization agreement with Daiichi Sankyo Company Ltd. (Daiichi Sankyo) that provided it with a license to commercialize laninamivir octanoate in Japan and entitled it to a royalty on those net sales. Laninamivir octanoate, which is marketed in Japan by Daiichi Sankyo as Inavir, was approved for sale by the Japanese Ministry of Health and Welfare for the treatment of influenza A and B in adults and children and for the prevention of influenza A and B. Laninamivir octanoate is a long acting NI for the treatment and prevention of influenza A and B. The patent relating to the structure of laninamivir octanoate expires in 2017 in the U.S., the EU, and Japan. The patent relating to hydrates and the crystalline form of laninamivir octanoate actually used in the product expires in 2021(not including extensions) in the U.S. and EU and in 2024 in Japan. The dry-powder inhaler device patent portfolio, which includes TwinCaps, is owned by Hovione International Limited and is licensed to the company and Daiichi Sankyo worldwide for the prevention and treatment of influenza and other influenza-like viral infections. These patents would expire in 2029 in the U.S., and in 2027 in the EU and Japan. Vapendavir, is an oral antiviral, is being developed to treat HRV infections. The company owns the vapendavir patent portfolio, and issued claims under this portfolio would begin to expire in some countries in December 2021, not including extensions. The company also owns a patent portfolio focused on developing oral antivirals for RSV. Its RSV patent portfolio consists of various patent filings directed to several compound series, with the earliest projected expiries of such patents ranging from late-2024 to late-2031. Issued patent claims covering BTA-C585 would begin to expire in 2031. Regulatory Matters In the U.S., the company’s activities are subject to regulation by various federal, state and local authorities in addition to the United States Food and Drug Administration, including the Centers for Medicare and Medicaid Services, other divisions of HHS (the Office of Inspector General), the U.S. Department of Justice and individual U.S. Attorney offices within the Department of Justice, and state and local governments.
biota pharmaceuticals inc
2500 Northwinds Parkway
Alpharetta, GA 30009
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